MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0292

Device Problems Over-Sensing (1438); Pocket Stimulation (1463); Device Dislodged or Dislocated (2923)

Patient Problem Muscle Stimulation (1412)

Event Date 02/18/2016

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the patient presented to the clinic with complaints of diaphragmatic stimulation.When attempting to program around the stimulation, crosstalk of the atrial pace on the ventricular channel was seen.It was noted that when the sensitivity of the right ventricular (rv) lead was reprogrammed to 1.0 millivolts the crosstalk disappeared.An x-ray was taken which revealed a micro-dislodgement.Subsequently a revision procedure was performed where the rv lead was successfully repositioned.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5601077
• MDR Text Key: 43441645
• Report Number: 2124215-2016-03969
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2017
• Device Model Number: 0292
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR